Head-of-bed position after clot-removal stroke therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this interventional trial, adults who have undergone endovascular thrombectomy for large vessel occlusion are randomized to be kept with the head of the bed at 0 degrees or at 30 degrees or higher. The aim is to see if body positioning after clot removal influences functional outcomes after stroke. The study compares two post-procedure head positions and uses standard care for all other aspects of recovery. Eligibility requires confirmed LVO treatment, consent capability, and specific clinical criteria; exclusions include pre-procedure ventilatory support and certain heart conditions. The trial is sponsored by the Population Health Research Institute with sites in Ontario, Canada.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 years or older on the date of randomization
* Endovascular thrombectomy (EVT) for large vessel occlusion (LVO) in the anterior circulation, according to current guidelines and local standards of clinical care. The definition of LVO may include the intracranial segment of the internal carotid artery (ICA), and/ or the M1 segment (proximal, mid, distal) of the middle cerebral artery (M1-MCA), and/ or the proximal M2 segment of the MCA (M2-MCA)
* Capable of giving signed informed consent either independently, or by a legally authorized representative (LAR), or via a deferred consent process approved by the relevant ethics committee, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

* Mechanical ventilatory support for acute medical condition prior to procedure (i.e. required for reasons other than procedure)
* Symptomatic congestive heart failure, chronic obstructive pulmonary disease, or any other medical condition that would make either HoB position inappropriate for patient care in the judgement of the investigator.
* Any condition, such as but not limited to, agitation/ delirium or severe nausea/ vomiting, that, in the view of the investigator, is expected to significantly impede maintaining the assigned HoB
* Any condition with life expectancy of less than 3 months
* Inability to randomize within 1 hour from the end of the EVT

Where it's running

• Health Sciences North
  Greater Sudbury, Ontario, Canada Recruiting
• Hamilton General Hospital
  Hamilton, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Aristeidis Katsanos, MD — Population Health Research Institute
• Study coordinator: Samantha Block, BSc
• Email: hobit@phri.ca
• Phone: 905-521-2100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.